BEUDAMED
    FDA Recall Terminated

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    Recall: Z-1924-2016 · Initiated May 5, 2016

    Recall

    Recall Number
    Z-1924-2016
    Event Number
    74176
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 5, 2016
    Posted
    June 7, 2016
    Terminated
    June 16, 2017
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936

    Description

    Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

    Reason

    This recall has been initiated due to the product labeled with the incorrect expiration date.

    Action

    MedComp sent a Product Recall letter dated May 5, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to evaluate their inventory and quarantine for the return of all un-used affected product. They were asked to contact Customer Service for a Return Goods Authorization (RGA) number at 215-256-9191.

    Distribution

    US Distributed to: FL, TX, NC

    Quantity

    VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).